This invention relates to a new and improved gastrostomy device with a flexible, collapsible internal retention dome. This retention dome improves the ease of insertion by collapsing down in size as the gastrostomy device is pulled down the esophagus of a patient during a placement procedure. The collapsibility of the retention dome also reduces the risk of tissue and stoma damage, and reduces patient trauma during a subsequent external traction removal procedure.
Various types of gastrostomy devices have been installed in patients by means of a percutaneous insertion, a surgical placement, a radiological placement or others. The procedures employed generally follow those known as the Sachs-Vine procedure, the Gauderer and Ponsky procedure, and others. Typical patents describing these procedures and publications of the technique are set forth in U.S. Pat. Nos. 4,861,334; 4,900,306; and 5,080,650.
Once installed, these devices are retained in place by an internal retention member. Various types of these internal retention members currently exist, one type being a molded or permanently attached flange element, and another type being a collar and balloon.
Removal of gastrostomy devices is needed upon conclusion of enteral nutrition of a patient, or if the device were to be replaced with another enteral feeding device (e.g. an inflatable, replaceable gastrostomy tube), and various techniques are currently used for this removal procedure. These techniques include 1. cutting the gastrostomy tube at skin level and retrieving the bumper endoscopically; 2. cutting the gastrostomy tube at skin level and allowing the flange or collar to pass through the gastro-intestinal tract and be expelled by excretion; or, 3. physically pulling the internal retention device through the patient's stoma.
There are problems associated with all three of the above prior art removal techniques. For example, the endoscopic retrieval process places the patient at high risk during the procedure. Some of the risks involved are esophageal tissue damage and possible blockage of the trachea by the flange or collar upon retraction which could result in death.
Another risk occurs in allowing the flange or collar to pass through the gastrointestinal tract which may cause intestinal or bowel blockage.
Still another risk arises when these prior art devices are removed from a patient by means of external traction techniques, since they have been known to cause considerable trauma and excessive bleeding to patients.
Consequently, the device of the present invention is designed for placement by either of the aforementioned percutaneous endoscopic or other types of procedures, and improves upon prior art devices during placement of the device and also during the external traction removal procedure.